(104 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is purely mechanical.
No
This device is designed to collect and remove obstructing material from central venous catheters and to provide samples for analysis, which are diagnostic and maintenance functions, not therapeutic. Its function is to restore or improve catheter flow rate and collect samples, not to treat a disease or condition in the patient.
No
The device is described as being intended to "collect and remove obstructing material from the internal lumen surface of an indwelling central venous catheter to restore or improve catheter flow rate" and to "provide a biofilm or fibrin sample which is suitable for microbiological analysis." While it collects a sample for analysis, its primary specified function is not to diagnose a condition, but rather to restore catheter function and provide a sample for subsequent analysis.
No
The device description clearly lists multiple physical components (gloves, masks, swabs, access device, vacutainer tubes, test brush, drape, measure tape, clamp, specimen transport bag) and describes the physical construction of the test brush. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the CRS Fibrin Analysis Catheter Testing System (FACTS) is likely considered an IVD (In Vitro Diagnostic) device, or at least has a significant IVD component.
Here's why:
- Intended Use: The intended use explicitly states that the system is intended "to provide a biofilm or fibrin sample which is suitable for microbiological analysis." This is a key characteristic of an IVD device – it's designed to collect a sample for subsequent diagnostic testing performed in vitro (outside the body).
- Device Description: The kit includes items like vacutainer tubes and a specimen transport bag, which are directly related to sample collection and handling for laboratory analysis.
- Microbiological Analysis: The mention of "microbiological analysis" confirms that the collected sample is intended for diagnostic testing to identify microorganisms.
While the device also has a therapeutic function (removing obstructing material to restore flow), the inclusion of sample collection for microbiological analysis strongly points towards it having an IVD purpose.
In summary, the FACTS system serves a dual purpose: a therapeutic one (restoring catheter flow) and a diagnostic one (providing a sample for microbiological analysis). The diagnostic aspect makes it fall under the purview of IVD regulations.
N/A
Intended Use / Indications for Use
The CRS Fibrin Analysis Catheter Testing System (FACTS) is intended to collect and remove obstructing material from the internal lumen surface of an indwelling central venous catheter to restore or improve catheter flow rate, and to provide a biofilm or fibrin sample which is suitable for microbiological analysis.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The CRS Fibrin Analysis Catheter Testing System (FACTS) is an accessory to peripherally inserted central catheters (PICC). Each single use FACTS kit contains complete instructions for use, 2 pr nitrile powder free gloves (med), 2 each ear loop procedure face masks, 3 each alcohol swabs, 1 each BD Lure-Loc Access Device, 2 each vacutainer tube, 1 each test brush in sheath, 1 each over wrap drape, 1 each measure tape, 1 each clamp and 1 cach specimen transport bag. The testing brush consists of nylon bristles wound onto a flexible stainless steel wire. The testing brush is enclosed within a polysheath that is heat sealed at the distal end and again at the brush handle and is attached by color coded rings. The different rings indicate the diameter of the testing brush bristles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal lumen surface of an indwelling central venous catheter
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
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EXHIBIT 2
510(k) Summary CRS Medical Diagnostics, Inc. 662 Capitol Drive Pewaukee Wisconsin 53072 Tel 262-264-0047 Fax 262-264-0051 July 10, 2007 Contact: Robert S. Brewer, Chairman of the Board
DEC 2 0 2007
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- Identification of the Device: Proprietary-Trade Name: CRS Fibrin Analysis Catheter Testing System (FACTS) Classification Names: Accessory to, Percutaneous, implanted, long-term intravascular catheter, product code LJS Common/Usual Name: Endoluminal Brush
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- Indications for Use (intended use) The CRS Fibrin Analysis Catheter Testing System (FACTS) is intended to collect and remove obstructing material from the internal lumen surface of an indwelling central venous catheter to restore or improve catheter flow rate, and to provide a biofilm or fibrin sample which is suitable for microbiological analysis.
-
- Description of the Device: The CRS Fibrin Analysis Catheter Testing System (FACTS) is an accessory to peripherally inserted central catheters (PICC). Each single use FACTS kit contains complete instructions for use, 2 pr nitrile powder free gloves (med), 2 each ear loop procedure face masks, 3 each alcohol swabs, 1 each BD Lure-Loc Access Device, 2 each vacutainer tube, 1 each test brush in sheath, 1 each over wrap drape, 1 each measure tape, 1 each clamp and 1 cach specimen transport bag. The testing brush consists of nylon bristles wound onto a flexible stainless steel wire. The testing brush is enclosed within a polysheath that is heat sealed at the distal end and again at the brush handle and is attached by color coded rings. The different rings indicate the diameter of the testing brush bristles.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices.
1
Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally oriented. The words are stacked on a single line and are left-aligned.
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
DEC 2 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CRS Medical Diagnostics, Incorporated C/O Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K072518
Trade/Device Name: CRS Fibrin Analysis Catheter Testing System (FACTS) Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: August 29, 2007 Received: September 28, 2007
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Kamm
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Cunon
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number
Device Name: CRS Fibrin Analysis Catheter Testing System (FACTS)
Indications For Use:
The CRS Fibrin Analysis Catheter Testing System (FACTS) is intended to collect and remove obstructing material from the internal lumen surface of an indwelling central venous catheter to restore or improve catheter flow rate, and to provide a biofilm or fibrin sample which is suitable for microbiological analysis.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amr
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection of Anosthesionogy, Gene
510(k) Number: _ Ko725)K